Regulations & quality and bioproduction

Level 1 -

Introduction to the culture of good manufacturing practices

Presentation

Why participate?

Raise awareness of GMP and acquire a common language to collaborate effectively with partners and subcontractors

Training Context:

Good Manufacturing Practices (GMP or cGMP) are a regulatory milestone in the development of biopharmaceuticals. While they are routine in some organizations — especially CDMOs — it is essential that all stakeholders are aware of these practices to ensure project success.

Learning objectives

  • Define and understand the origins and key challenges of pharmaceutical GMP (Good Manufacturing Practices), and what they imply for both the company and the project
  • Understand the regulatory framework governing GMP
  • Embrace the spirit of GMP and the core concepts from the main GMP chapters, in order to develop a shared language with industry partners and subcontractors
  • Understand how product/process lifecycle, risk assessment, traceability, and data integrity are integrated into GMP
  • Gain a synthesized overview of GMP as applied to advanced therapy medicinal products (ATMPs)

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Business leaders, R&D researchers, engineers, pharmacists, CSOs, project managers, academic researchers and engineers.

Prerequisites

Have knowledge of drug development processes

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

Sessions

No session available

Trainers

Huant Jérémy

Jeremy

HUANT

Business Unit Director
AGILAE Qualie

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.

When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.

For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr